Issam Zineh

FDA Director, Office of Clinical Pharmacology, OTS, CDER

Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the CDER Medical Policy Council (2016-present), and others. Dr. Zineh also leads CDER’s Model-informed Drug Development (MIDD) program. Dr. Zineh leads a staff of 246 regulatory, research, policy, communications, program/project management, and administrative staff in FDA’s efforts to enhance drug development, optimize pharmacotherapy, and promote innovation through clinical pharmacology and experimental medicine principles.